Drugs
FDA says it will not object to use of certain qualified health claims that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease. The statement came in an agency response to a 4/
Drugs
International Academy of Compounding Pharmacists executive vice president Scott Brunner says FDA “has overreached in implementing provisions” of the Drug Quality and Security Act of 2013, “all but halting common compounding practices that have been safely performed for years and on which patients with legitimate need for compounded medications rely.
Drugs
FDA says it is developing scientific tools to facilitate evaluations of peptides and proposed generic equivalents. In an online Regulatory Science Impact Story, the agency discusses the scientific challenge for approval of generic peptide drug products and its research to support development and evaluation of peptide drug products. “Different types
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says there are important potential enhancements that can be made to FDA’s current benefit/risk framework, including incorporation of the patient’s voice throughout the drug development lifecycle and utilization of patient experience date to inform regulatory decision-making. Commenting on an
Devices
FDA has approved a Philips PMA for its HeartStart OnSite defibrillator and HeartStart Home defibrillator and the relevant supporting accessories. The company says the two defibrillators are the only over-the-counter automated external defibrillators available to consumers in the U.S. Also, the HeartStart Home defibrillator is the only
Drugs
FDA is asking Congress for statutory improvements to its citizen petitions process. In a 6/19 Senate Committee on Aging hearing on drug prices, CDER director Janet Woodcock said that FDA would like “greater authority to summarily deny petitions submitted with the primary purpose of delaying approval of an application
Drugs
RXQ Compounding has recalled all sterile human and animal products within expiry due to a lack of sterility process assurance associated with sterile product manufacturing. A recall notice says that RXQ is voluntarily ceasing all sterile production at its current location while it transitions to the company’s new outsourcing
Drugs
A 10/16-10/26/18 FDA inspection at PRL, Inc., Lobelville, TN, found multiple serious violations of agency regulations for current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. A 6/6 Warning Letter says the violations cause the dietary supplements manufactured at the
Drugs
FDA says it is enhancing the Paragraph 4 patent certification list by adding several additional data points, including the status of any 180-day exclusivity decisions for individual drug products and information about the dates of first approval, marketing status, and expiration dates of blocking patents. FDA acting commissioner Ned
Drugs
FDA has granted Abeona Therapeutics a fast track designation for ABO-202, a novel one-time AAV9 gene therapy for CLN1 disease. The therapy is designed to deliver a functional copy of the PPT1 gene to the central nervous system and peripheral organs using a combination of intravenous and intrathecal
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Lateral Expandable Spacer System for use in treating spinal disorders. The device, which is available in several lordotic options, allows for post-packing in situ, has anatomically convex endplates and is made using Life Spine’s proprietary Osseo-Loc
Drugs
The Association for Accessible Medicines (AAM) says it supports the administration’s decision not to include pharmaceuticals and certain pharmaceutical inputs on the most recent list of Chinese exports that would face U.S. tariffs when imported into this country. In a letter to U.S. trade representative Robert Lightizer,
Drugs
FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) and its use in treating patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The anti-PD-1 therapy’s approval was based on tumor
Drugs
A 5/12-5/30/18 FDA inspection at the Tropical Seas drug manufacturing facility in Holly Hill, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 5/15 Warning Letter also says the firm produces several products that the agency considers
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration” (OMB Control Number 0910-0847). The agency says that understanding patients, consumers, and healthcare professionals’ perceptions and behaviors plays an important role
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). FDA’s regulations authorize it to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set
Devices
Cook Medical has recalled its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received about balloons bursting below the rated burst pressure. The company says that while there have been no reports of malfunctions, deaths, or injury reported for the balloon issue, there
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. PRL, Inc. Lobelville, TN (6/6): FDA inspected the firm 10/2018 and cited multiple serious GMP violations for dietary supplements. The letter also says the agency collected labels
Drugs
FDA scientists say they have developed a poliovirus assay that is faster and more versatile than those now used to monitor polio vaccine production, assess patient responses to polio vaccines during clinical trials, and do environmental surveillance of vaccine poliovirus. They say the new assay also is the first to
Drugs
Researchers from Harvard Medical School and the University of Calgary say there are similar development times for small molecules and biologic drugs, leading to questions about the longer patent period under the Biologics Price Competition and Innovation Act. “Our study reviewed pre-market times for all new drugs approved by
Devices
Department of Homeland Security’s National Cybersecurity and Communications Integration Center has issued a cybersecurity alert on BD’s Alaris Gateway Workstation, which is used to integrate infusion pump systems with hospitals’ central clinical information systems. The cyber threat could “allow unauthorized arbitrary code execution, which could allow an attacker
Drugs
A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed journals. “Postmarketing commitments are studies that drug companies agree to conduct at the time of FDA approval, and are not required by statute or regulation,